Amend 1 to RFQ-20-114 SF-30.pdf

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT 1. CONTRACT ID CODE

OMB#0990-0115

PAGE OF PAGES

2. AMENDMENT/MODIFICATION

One

3. EFFECTIVE DATE

May 27, 2020

4. REQUISITION/PURCHASE REQ. NO.

45208-PO-20-231

5. PROJECT NO. (If applicable)

6. ISSUED BY CODE

Great Plains Area Indian Health Service Attn: Nichole R. Lerew, Supervisor Contract Specialist Room 309, Federal Building 115 4th Avenue Southeast Aberdeen, SD 57401

7. ADMINISTERED BY (If other than Item 6) CODE

8. NAME AND ADDRESS OF CONTRACTOR (No., street, county, State and ZIP Code)

(X) 9A. AMENDMENT OF SOLICITATION NO.

RFQ-20-114

X

9B. DATED (SEE ITEM 11)

05/21/2020

10A. MODIFICATION OF CONTRACT/ORDER

NO.

10B. DATED (SEE ITEM 13)

CODE FACILITY CODE

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers is extended, is not extended.

Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods:

(a) By completing Items 8 and 15, and returning ____1___ copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

12. ACCOUNTING AND APPROPRIATION DATA (If required)

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS,

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

(X) A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT

ORDER NO. IN ITEM 10A.

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation date, etc.).

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER (Specify type of modification and authority)

E. IMPORTANT: Contractor Offers is not, is required to sign this document and return ___________ copies to the issuing office.

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

Amend RFQ-20-114 as follows:

A. See attached revised Statement of Work to reflect updates to sections 5.1, 5.2 and 5.4.

B. There are no other changes made by reason of this amendment.

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15A. NAME AND TITLE OF SIGNER (Type of print)

16. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)

CRAIG J. WELLS, IHS-CO-19-0009

15B. CONTRACTOR/OFFEROR

(Signature Of person authorized to sign)

15C. DATE SIGNED

16B. UNITED STATES OF AMERICA

(Signature Of Contracting Officer)

16C DATE SIGNED

NSN 7540-01-152-8070 30-105 STANDARD FORM 30 (REV. 10-83)

PREVIOUS EDITION UNUSABLE Prescribed by GSA

FAR (48 CFR) 53.243

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Statement of Work Medical Physicist Services

Rosebud Comprehensive Health Care Facility

Section 1: General Information

1.1 General: This is a non-personal services contract to provide medical physics services for the Rosebud Comprehensive Health Care Facility (RCHCF). The Government shall not exercise any supervision or control over the contract service providers performing the services herein. Such contract service providers shall be accountable solely to the Contractor who, in turn is responsible to the Government.

1.2 Period of Performance: 1. Will be one (1) year from the Date of Award with four (4) one

(1) year option periods.

1.3 Place of Performance: Rosebud Comprehensive Healthcare Facility PO Box 400 Rosebud, South Dakota 57570

1.4 Hours of Operation: All work shall be performed during business hours of 8:00 am to 5:00 PM. If a service has begun during regular business hours and it must be completed before any patients can be imaged according to the American College of Radiology (ACR), The Joint Commission (TJC), or the Mammography Quality Standards Act (MQSA), then the physicist must complete the service.

1.5 Type of Contract: The government will award a Firm Fixed Price contract.

1.6 Invoicing: All invoices from the contractor shall be submitted electronically by email to the Property & Supply Supervisor for Payment Processing.

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• -Invoice Contact Information: 605 747 0411

• -Invoice email: Sharon.lapointe@ihs.gov

Section 2: Definitions & Acronyms

2.1 Definitions:

Contractor. A supplier or vendor awarded a contract to provide specific supplies or service to the government.

Work Day. The number of hours per day the Contractor provides services in accordance with the contract is an 8 hour day.

2.2 Acronyms:

AAPM

ACR

CBCT

CFR

COR-NA

CT

FOV

HVL

IEC

MQSA

MRI

NCRP

PET

QA

RSO

SMPTE

SOW

SPECT

TJC

American Association of Physicist in Medicine American College of Radiology Cone Beam Computed Tomography Code of Federal Regulations Contracting Officer Representative-Non Applicable Computed Tomography Field of View Half Value Layer International Electro technical Commission Mammography Quality Standards Act Magnetic Resonance Imaging National Council for Radiation Protection Positron Emission Tomography Quality Assurance Radiation Safety Officer Society of Motion Picture and Television Engineers Statement of Work Single-Photon Emission Computed Tomography The Joint Commission

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Section 3: Government Furnished Property, Equipment, and Services

None

Section 4: Contractor Furnished Items and Services

The Contractor shall provide all equipment, supplies, management, supervision, personnel, and transportation necessary to assure that all services are in accordance with the contract and all applicable laws and regulations. The contractor shall ensure all work meets performance standards specified in this Statement of Work (SOW).

Section 5: Specific Tasks

The Contractor shall comply with radiation protection standards in 29 CFR 1910.1096 and immediately report any unsafe conditions with the potential to adversely impact the facility radiation workers or patients to the Radiation Safety Officer (RSO).

5.1 General Requirements

A. All work shall be performed by a Qualified Medical Physicist (QMP) or the QMP must provide oversight for providing direct quality control supervision during measurements made by a medical physicist assistant/technician. A Qualified Medical Physicist is a person who is certified by the American Board of Radiology, American Board of Medical Physics, or the Canadian College of Physicists in Medicine. The contractors must submit evidence of board certification with their quote.

5.2 Required Services

A. All imaging equipment shall be inspected at least annually.

not to exceed 14 months. Other inspections as defined below (new equipment, repairs, shielding (lead aprons), etc.) shall be completed as needed. A complete electronic report in “pdf” format shall be provided to Biomedical Engineering and the Radiology Supervisor within 30 days after completion of the inspection. Missed or errors in performance for required elements will be corrected at the expense of the contractor. If errors are found in reports, corrections in “pdf” form will be submitted expeditiously.

B. The qualified diagnostic Medical Physicist shall perform imaging equipment (x-ray equipment, Mammo, CT, ultrasound units, and Dental units) inspections to ensure

Page | 4 compliance with the current Regulatory agency requirements. Any deficiencies or non-conformances discovered during the inspection shall be verbally communicated to Biomedical Engineering and the RSO prior to the qualified diagnostic medical physicist leaving the facility. Deficiencies or non-conformances which represent unsafe conditions with the potential to adversely impact the facility radiation workers or patients must be reported to the RSO immediately upon discovery.

C. The qualified diagnostic medical physicist shall perform acceptance testing of all new or relocated imaging equipment prior to first clinical use. The acceptance testing shall comply with ACR and MQSA requirements. Any deficiencies or non-conformances discovered during the inspection shall be verbally communicated to Biomedical Engineering, RSO and Radiology Supervisor, prior to the qualified diagnostic medical physicist leaving the facility. Deficiencies or non-conformances which represent unsafe conditions with the potential to adversely impact the facility radiation, workers, or patients shall be reported to Biomedical Engineering, RSO and Radiology Supervisor immediately upon discovery.

D. The qualified diagnostic medical physicist shall perform a full inspection of imaging equipment after repairs or modifications that may affect the radiation output or image quality where required. In cases where the unit may not be used clinically until inspected by a physicist, the inspection must be completed within 72 hours after the facility contacts the contractor, Any deficiencies or non-conformances discovered during the inspection shall be verbally communicated to Biomedical Engineering, RSO and Radiology Supervisor prior to the qualified diagnostic medical physicist leaving the facility. Deficiencies or non-conformances which represent unsafe conditions with the potential to adversely impact the facility radiation workers or patients shall be reported to Biomedical Engineering, RSO and Radiology Supervisor immediately upon discovery. Where acceptable, the physicist will review and accept the repairs report from Engineering.

E. The qualified diagnostic medical physicist shall provide consultation for additional services as needed, such as safety training, reading dosimetry badge reports, i.e.

F. The qualified diagnostic medical physicist shall review CT protocols at least annually.

G. The qualified diagnostic medical physicist will assume Radiation Safety Officer Duties, and responsibilities; this includes reviewing badge dose reports.

H. The qualified diagnostic medical physicist shall provide shielding design calculations for each new, replaced, or relocated x-ray imaging system. The calculations for each shall comply with the National Council for Radiation Protection and Measurements (NCRP) Report No. 147, and, for dental units, NCRP Report No. 145, and shall be documented in a written report which includes a diagram showing adjacent areas. The qualified diagnostic medical physicist shall perform a shielding survey to verify the structural shielding was installed per the shielding design report and complies with the design goals.

I. The qualified diagnostic medical physicist shall assist in the development of a comprehensive technical quality assurance (QA) program (e.g., technique charts, repeat/reject analysis monitoring, monitoring of exposure indices to radiographic image receptors, QA program for display monitors, QA for CT, monitoring of dose metrics from fluoroscopy studies), which

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Complies with ACR recommendations, for all modalities. The qualified diagnostic medical physicist shall review at least annually the QA program.

J. The qualified diagnostic medical physicist shall review the report from Engineering to verify compliance of any necessary corrective action performed to correct deficiencies found. The contractor will perform a follow-up inspection if necessary according to ACR, MQSA, or other relevant standards.

5.3 Equipment Inspections

The Contractor shall conduct equipment inspections or quality control surveys of the imaging equipment listed below. The Contractor shall ensure the imaging equipment’s compliance with applicable Federal regulations and ACR recommendations, and shall include, but not be limited to, monitoring the following basic performance characteristics.

A. Radiographic and Fluoroscopic Equipment

Physics inspections of radiographic and fluoroscopic equipment shall comply with the ACR Technical Standard for Diagnostic Medical Physics Performance Monitoring of Radiographic and Fluoroscopic Equipment. The performance of each radiographic and fluoroscopic unit must be evaluated at least annually. This evaluation should include, but not be limited to, the following tests (as applicable).

1) Integrity of unit assembly.

2) Collimation and radiation beam alignment.

3) Fluoroscopic system spatial resolution.

4) Automatic exposure control system performance.

5) Fluoroscopic automatic brightness control performance (high-dose-rate, pulsed modes, field-of-view [FOV] variation).

6) Image artifacts.

7) Fluoroscopic phantom image quality.

8) kVp accuracy and reproducibility.

9) Linearity of exposure versus mA or mAs.

10) Exposure reproducibility.

11) Timer accuracy.

12) Beam quality assessment (half-value layer).

13) Fluoroscopic entrance exposure rate (or air kerma rate). Maximum output and output using a phantom representing a standard size patient for all clinically used settings. [The mode of operation [e.g., magnification mode, frame rate, and any other mode selected) must be documented for each measurement.]

14) Fluorographic (image recording) entrance exposure rate (or air kerma rate) for cine imaging, if performed and entrance exposure (or air kerma) for spot images (if performed). Maximum output and output using a phantom representing a standard size patient for all clinically used settings. [The mode of operation (e.g., magnification mode, frame rate, etc.) must be documented for each measurement.]

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15) Image receptor entrance exposure.

16) Equipment radiation safety functions.

17) Patient dose monitoring system calibration. This includes, for radiographic systems, the metric of dose to the image receptor (IEC Exposure Index or proprietary index) and, for

Fluoroscopy systems, the displays of cumulative air kerma and, if available, DAP.

18) Display monitor performance.

19) Digital image receptor performance.

20) Grids used with portable x-ray units shall be imaged for uniformity.

21) For radiographic units, measurement of entrance skin exposure (or air kerma) for a standard size patient for common radiographic projections and comparison to published diagnostic reference levels and achievable doses (e.g., ACR practice parameter.

Note: The information on entrance exposure rates (or air kerma rates) from fluoroscopy and from fluorography, in Items (13) and (14) above, for each fluoroscope, shall be in a format suitable for providing to the physicians who operate the fluoroscope.

B. Digital Radiography (DR)

Physics inspections of DR equipment shall comply with the American Association of Physicist in Medicine (AAPM) Report Number 93, Acceptance Testing and Quality Control of Photostimulable Storage Phosphor Imaging Systems. The performance of DR must be evaluated at least annually. This evaluation should include, but not be limited to, the following tests (as applicable).

1) Component and Imaging Plate Physical Inspection and Inventory.

2) Imaging Plate Dark Noise and Uniformity.

3) Exposure Indicator Calibration.

4) Linearity and Auto-ranging Response.

5) Laser Beam Function.

6) Limiting Resolution and Resolution Uniformity.

7) Noise and Low-Contrast Resolution.

8) Spatial Accuracy.

9) Erasure Thoroughness.

10) Aliasing/Grid Response.

11) IP Throughput.

12) Positioning and Collimation Errors.

C. CT Scanners

The physics inspection shall conform to the 2012 ACR Computed Tomography Quality Control Manual or latest revision. The performance of each CT scanner shall be evaluated at least annually. This evaluation should include, but not be limited to, the following tests (as applicable).

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1) Review of Clinical Protocols.

2) Scout Prescription and Alignment Light Accuracy.

3) Image Thickness – Axial Mode.

4) Table Travel Accuracy.

5) Radiation Beam Width.

6) Low-Contrast Performance.

7) Spatial Resolution.

8) CT Number Accuracy.

9) Artifact Evaluation.

10) CT Number Uniformity.

11) Dosimetry (the scanner displayed CTDIvol values must be within +/- 20% of the measured

CTDIvol values).

12) Gray Level Performance of CT Acquisition Display Monitors.

D. Dental

The physics inspection shall conform to the Conference of Radiation Control Program Directors (CRCPD), Quality Control Recommendations for Diagnostic Radiography Volume 1 Dental Facilities July 2001. The performance of dental x-ray inspections shall be annually or every 2 years. This evaluation should include, but not be limited to, the following tests (as applicable).

1) Collimation.

2) Beam quality (half value layer).

3) Timer Accuracy and Reproducibility.

4) kVp Accuracy and Reproducibility.

5) mA or mAs Linearity.

6) Exposure Reproducibility.

7) Entrance Skin Exposure Evaluation, with comparison to published diagnostic reference levels and achievable doses (e.g., NCRP Report No. 172).

8) Technique Chart Evaluation.

9) Image uniformity (artifact evaluation).

Dental Cone Beam Computed Tomography (CBCT) Acceptance and Performance Testing

a) Acceptance Testing. Acceptance testing and measurements of air kerma at the isocenter for each kVp station for a range of clinically used mAs settings will performed initially when the CBCT unit is installed, and following any move of the CBCT to another area inside or outside the initial clinical site. This testing is to ensure that the equipment performance is in agreement with the manufacturer’s technical specifications.

b) Performance Testing. Each CBCT unit shall undergo periodic quality control tests to insure that the performance of the machine has not significantly deteriorated and is operating within the manufacturer’s technical specifications. This performance testing is performed by a qualified expert annually, at intervals not to exceed 14 months, and after repairs to the CBCT unit that may affect the radiation output or image quality.

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c) Some manufacturers provide a phantom and procedures to perform machine specific quality assurance (QA) tests. In cases where the manufacturer provides a phantom and procedures to perform specific tests but the tests are not included in this SOW, then the manufacturer’s machine-specific QA tests shall be performed in addition to the QA tests in this SOW.

Acceptance and Annual physics testing for Dental CBCT

a) Radiation output Repeatability

Make four measurements of the air kerma at the isocenter at a clinically used setting. The measurements should be less than +/-5% of the average of the five measurements and the measurements should be less than +/- 5% of the previous year’s measurement.

b) Radiation Output Reproducibility

Measure the air kerma at the isocenter for each kVp station and a range of clinically used mAs setting. Compare the results to the baseline values established at the initial acceptance testing. The values should be +/-5% of the baseline.

c) kVp Accuracy

Measure the kVp at all clinically used settings. The measured kVp should be +/-5% of the selected kVp.

d) kVp Repeatability

Make five kVp measurements each for two clinically used kVp settings. All measured values should be +/-5% of the mean kVp.

e) kVp Reproducibility

Measure the kVp at all available kVp settings. The measured values should be +/-5% of the baseline.

f) Beam quality

Measure the half value layer (HVL) for aluminum. The minimum shall comply with Section F.4.d of the Suggested State Regulations for Control of Radiation, Conference of Radiation Control Program Directors.

g) Radiation field of view (FOV)

Measure the width of the radiation field at the isocenter. The width of the beam should be 3 mm or 30% of the total nominal collimated width.

h) Image Quality

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Image the phantom provided by the manufacturer or another suitable phantom. Assess high contrast spatial resolution, uniformity of transaxial images, and image noise.

Imaging uniformity shall be assessed over the entire range of axial images.

i) Accuracy of Linear Measurements

Using images of an appropriate phantom, assess the accuracy of distance measurements.

j) Accuracy of Patient Dose Metric Indication

Assess the accuracy of the indicated dose metric (typically DAP).

k) Patient Dose Assessment

From a scan or scans using the facility’s standard techniques, record the dose metric (typically DAP) and compare to achievable levels and diagnostic reference levels (if available)

l) Review of the technical QA program

The qualified expert shall review the technical QA program. The review shall include a trend analysis of the QA data. The results of the technical QA program review shall be included in the written report. Any trends that identify problems shall be included in the report along with recommended corrective actions.

m) Display Monitors

Perform a visual analysis of the SMPTE test pattern.

i. Display the test pattern on the imaging console. Set the display window width/level to the manufacturer-specified values for the pattern. Do not set the window/level by eye; doing so invalidates the procedure.

ii. Examine the pattern to confirm that the gray level display in the imaging console is subjectively correct.

1. Review the line pair patterns in the center and at each of the corners.

2. Review the black-white transition.

3. Look for any evidence of “scalloping” (loss of bit depth) or geometric distortion.

iii. Use a photometer to measure the maximum and minimum monitor brightness (0% and 100% steps)

iv. Measure additional steps within the pattern to establish a response curve.

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v. Measure the brightness near the center of the monitor and near all 4 corners (or all 4 sides, depending on the test pattern used).

n) Viewing Conditions

Assess the viewing conditions for the area in which the monitor used to evaluation the CBCT studies is located.

E. Ultrasound

The physics inspection shall conform to the ACR performance tests for ultrasound. Testing should be done for all transducers clinically used with any unit employing more than one transducer. Ultrasound equipment shall be inspected semi-annually (every 6 months).

1) System Sensitivity/Penetration

This test should be done with the following settings:

• maximum transmit power

• proper receiver gain and TGC that allows echo texture to be visible in the deep region

• transmit focus at the deepest depth

The maximum depth of visualization is determined by comparing the gradually weakening echo texture to electronic noises near the bottom of the image.

2) Image Uniformity

Adjust the TGC controls and other sensitivity controls to obtain an image as uniform as possible.

• vertical or radially oriented streaks?

• dropouts?

• reduction of brightness near edges of the scan?

• brightness transitions between focal zones?

3) Electrical and Mechanical Safety and Cleanliness

• Are all cords and cables intact (no frays)?

• Are all transducers intact without cracks or delamination?

• Are the transducers cleaned after each use?

• Are the image monitors clean?

• Are the air filters clean?

• Are the wheel locks in working condition?

• Are the wheels fastened securely to the US unit and do the wheels rotate easily?

• Are all accessories (VCR, cameras, etc.) fastened securely to the US unit?

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4) Gray Scale Photography (if applicable) – Do either (a), (b), or (c).

a) For Scanners with a Discrete Bar Pattern

Count the number of distinct gray bar steps on the viewing monitor. Then count the number of steps visualized in the gray bar on the hard copy image.

b) For Scanners with a Continuous Gray Bar Pattern

Use calipers to measure the length of the black-to-white transition of the gray wedge on the viewing monitor. If the relative length of the black-to-white transition on the hard copy image is less, document how much is missing.

c) For Laser Imager (Hard Copy Device)

Prior to filming any images, an SMPTE test pattern created by the Society of Motion Picture and Television Engineers (SMPTE), should be printed using the appropriate window width (WW) and window level (WL). If you are unfamiliar with this procedure, you should review Gray et al., “Test pattern for video display and hard-copy camera,” Radiology 145:519-527 (1985), and then contact your local service engineer for assistance. When printed, the 95% density patch within the 100% square and the 5% density patch within the 0% square should be visible, and there should be no notable distortions or artifacts present. If these criteria are not met, contact your service engineer for laser camera calibration before proceeding with any filming.

5) Hard Copy Output Quality Test (Digital) (if applicable)

This test, or a similar test specifically recommended by the hard copy equipment manufacturer.

Required Test Equipment

• Densitometer

• SMPTE Test Pattern or another similar test pattern or phantom image having a wide range of gray scales.

The same test image should be used each time.

F. Display Monitors

The annual performance evaluation conducted by the diagnostic medical physicist includes testing of image acquisition display monitors for maximum and minimum luminance, luminance uniformity, resolution, and spatial accuracy. The image acquisition display monitors for nuclear medicine, CT, and MRI units shall be tested.

G. Mammography-MQSA testing per requirement

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5.4 Equipment List

Description X-ray Units Planned replacement or addition

CT: Cannon Aquillion 64 1

Dental: Provecta 70 5

Dental: Gendex 900 2

Dental: GX DP-300 1

Fluoro & X-ray : GE Precision 500P 1

Fluoro & X-ray : 0

Portable Fluoro: Ziehm C-arm 1

Fluoro: 0

Fluoro: 0

Fixed X-ray: Cannon TRAD 1 Portable X-ray: Shimadzu 2

Cannon Apoilo 1 GE Voluson 1

Mammo: Dimensions 1